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NCT05326412 · ClinicalTrials.gov registry record · Phase 2
Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 49
- Enrollment target
NCT05326412 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 49 participants.
The verdict
NCT05326412, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-care (SoC) mono (long-acting β2-agonist \[LABA\]) or long-acting muscarinic antagonist \[LAMA\]), double (inhaled corticosteroid \[ICS\] + LABA, LABA + LAMA or ICS + LAMA), or triple (ICS + LABA + LAMA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD). Part A will consist of participants who are former smokers with COPD; Part B will consist of participants who are current smokers with COPD. The total study duration for each part (Part A and Part B) is approximately 36 weeks: * 4-week screening period * 12-week treatment period * 20-week followup period
Interventions
- DRUG Itepekimab SAR440340
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2022-05-19 |
| Est. Completion | 2025-07-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05326412
The ClinicalTrials.gov registry entry for NCT05326412 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Itepekimab SAR440340 is the first listed.
NCT05326412 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05326412 about?
NCT05326412 is a clinical study titled "Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD". This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab (anti-IL-33-mAb) and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years. This study consists of participants who have been on a standard-of-c...
What is the current status of trial NCT05326412?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2022-05-19. Estimated completion is 2025-07-25.
What interventions are being tested in trial NCT05326412?
The interventions under investigation include: Itepekimab SAR440340 (DRUG).
Who is sponsoring clinical trial NCT05326412?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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